A coalition of 20 consumer, public health and patient advocacy
groups last week asked the Institute of Medicine to add at least
three consumer representatives to a stakeholder panel that will
draw up a list of priority projects for comparative
effectiveness spending in the economic stimulus bill. The letter
pointed out that the proposed 16-member committee was well
stocked with physician specialists, insurers, Medicare experts
and technology assessors, but only had one patient
representative. "We strongly urge you to add additional consumer
and patient groups, and representatives of ethnic/minority
communities, to the committee so that it is properly balanced,"
the letter, whose signatories included the Center for Science in the Public Interest, said. "To ensure their independent perspectives and substantive contributions, these representatives should have a solid understanding of research methodology and not have financial ties to companies that make medical products or provide medical treatment."

Hill Panel Charges ATSDR Ignored Health Risks

The Agency for Toxic Substances and Disease Registry (ATSDR)
ignored or trivialized health risks at numerous hazardous waste
sites, witnesses charged at a House Committee on Science and Technology oversight hearing last
week. Under the 1980 Superfund law, ATSDR at the Centers for
Disease Control and Prevention is responsible for identifying
risks to human health posed by toxic cleanup sites. Critics said
the agency repeatedly failed to confront producers of toxic
waste and used questionable data to downplay the concerns of
people living in the areas. "The scientific nihilism and lack of
respect for the integrity of scientific investigation ... surely
compromises the stated mission of this agency," charged Ronald
Hoffman of the Mount Sinai School of Medicine in New York, who
worked with the agency on the discovery of a cluster of rare cancers near a Superfund site in Pennsylvania and later saw the findings discounted by the agency.

An accompanying committee report also cited the agency's response to formaldehyde contamination in Federal Emergency Management Agency trailers given survivors of hurricanes Katrina and Rita and the suppression of a Great Lakes pollution study. The report accused Howard Frumkin, director of the Center for Environmental Health at ATSDR, of having "a laissez faire attitude towards the
scientific integrity of the documents and data his agency relies
upon to make critical public health decisions. ... [S]cientific
integrity appears to take a back seat to political expediency"
at the agency, according to the report. Committee chairman Brad
Miller suggested Congress may require peer review of ATSDR health assessments. "It is hard to know how Congress can require ATSDR's leadership to have the guts to resist political pressure and insist on scientific integrity," Miller said.

Pain Doctor Fabricated Data in Studies

Scott Reuben, a prominent pain specialist at Baystate Medical
Center in Springfield, MA with financial ties to the
pharmaceutical industry, allegedly fabricated data in 21 medical
studies claiming benefits from the pain relievers Vioxx and
Celebrex. The studies, at least 13 of which have now been
withdrawn, were published in leading anesthesiology journals
between 1996 and 2008, according to Anesthesiology News. Hal Jenson, the chief academic officer at
Baystate Medical, said a routine audit last spring flagged discrepancies in Reuben's work. Reuben is on indefinite leave from his post at Baystate, and no longer holds an appointment as a professor at Tufts University's medical school, the Wall Street Journal
reported. Reuben, speaking through his attorney, said he
cooperated fully with the peer review committee investigating
the alleged scientific fraud. "There were extenuating
circumstances that the committee fairly and justly considered,"
the attorney said, but didn't explain what they were. Reuben
served on the speaker's bureau and received research funding
from Pfizer, which makes Celebrex.

Obama: Shield Science from Politics

President Obama issued a presidential memorandum last week aimed at insulating federal government scientific decisions from political influence, the Washington Postreported. The president asked the director of the White House Office of Science and Technology Policy to insure that "there should be transparency in the preparation, identification and use of scientific and technological information in policymaking." The order also requires scientists and technology professionals hired for positions in the executive branch to have "scientific and technological knowledge, credentials, experience, and integrity."

Appointees Influenced Cal. Energy Commission Study

The California Energy Commission's staff recommendation that
consumers get a price break on so-called hot fuel was altered by
two of the state agency's commissioners, at least one of whom
had family ties to the oil industry, according to documents
released by Consumer Watchdog, a California-based group. The initial staff analysis was based on the fact that motorists get less energy per gallon of gasoline when the fuel's temperature rises about 60 degrees Fahrenheit. The documents suggested CEC commissioner James Boyd, whose wife is a longtime lobbyist for the Western States Petroleum Association, and another commissioner changed staff conclusions in a hot fuel study in ways that protected oil industry interests, according to the consumer group. The California legislature had asked the commission for a cost-benefit analysis of the issue.

National Science Foundation Draws Hill Scrutiny

Sen. Charles Grassley (R-IA) last week asked the inspector general's office of the National Science Foundation to investigate the agency's extramural grants program for conflicts of interest. Grassley requested that "at a minimum" the inspector general determine the number and nature of financial conflicts of interest reported by the grantee institutions to NSF; the extent to which the NSF oversees financial conflicts of interest of grantee institutions, primary investigators and other senior investigators; and how NSF manages those conflicts. Last year, the inspector general for the department of Health and Human Services identified major shortcomings in the National Institutes of Health's management of financial ties between its extramural researchers and the private sector.

Odds and Ends

The Food and Drug Administration approved Menaflex, a device to treat knee injuries, despite repeated rejections by agency scientists and after lobbying by the device's maker, ReGen Biologics, according to a Wall Street Journalinvestigation. ... The Obama administration asked a federal appeals court to delay hearings on smog limits to give the Environmental Protection Agency time to review controversial Bush-era standards, which ignored recommendations for stricter standards from the EPA's Clean Air Scientific Advisory Committee, the New York Timesreported. ... The Obama administration is fast-tracking its response to the Supreme Court's 2007 climate decision with plans
to issue a mid-April finding that global warming threatens both
public health and welfare, according to an internal EPA
document obtained by Greenwire. ... EPA Administrator Lisa Jackson has put on hold negotiations between the agency and Dow Chemical on cleanup of dioxin contamination surrounding the company's plant in Michigan; an EPA regional administrator lost her job last year after demanding that the company clean up the contaminated sites. ...

Cheers and Jeers

Cheer to Anesthesiology News for reporting that Scott Reuben, a
well-known anesthesiologist, allegedly fabricated data in at
least 21 studies that led to multiple retractions. (See story
above)

Jeer to Stephen Smith of the Boston Globe for failing to disclose that René-Olivier Mirimanoff, a radiation oncologist at the University Hospital in Lausanne, Switzerland, received
(registration required) funding from, consulted for and sits on
the advisory board of Schering-Plough. Smith's article highlighted a study authored by Mirimanoff and published
in the journal Lancet Oncology that claimed the chemotherapy drug temozolomide, which is made by Schering-Plough, is effective for treating brain cancer when combined with radiation treatment.